Usability Engineering in Medical Devices based on IEC 62366-1:2015+AMD1:2020 Implementation Training

Usability engineering plays a critical role in ensuring that medical devices are safe, effective and intuitive for their intended users. Poor usability can contribute to use-errors that may compromise patient safety, making usability engineering an essential element of modern medical device development and regulatory compliance. This two-day implementation training provides participants with a practical understanding of the requirements of IEC 62366-1:2015+AMD1:2020 and its application throughout the medical device lifecycle. The training explains how usability engineering can be systematically integrated into product development while demonstrating its relationship with quality management, risk management and regulatory expectations. Participants will gain an understanding of the usability engineering process, including establishing the use specification, identifying known and foreseeable use-related hazards, defining user interface requirements, planning and performing usability evaluations. The training also explains how IEC 62366 interfaces with ISO 14971:2019, ISO 13485:2016.

DAY 1 - Fundamentals of Usability Engineering and Regulatory Requirements

• Introduction to usability engineering
• Overview of IEC 62366-1:2015
• Regulatory expectations for usability engineering
• Relationship with ISO 14971:2019, ISO 13485
  
• Understanding intended use, intended users, use environments and user profiles
• Developing the Use Specification
• Identifying known and foreseeable use-related hazards
• Hazard-related use scenarios and use-related risk considerations

DAY 2 - Implementing the Usability Engineering Process

• Establishing user interface characteristics and usability requirements
• Planning usability engineering activities throughout the product development lifecycle
• Formative evaluation and iterative design considerations
• Summative evaluation (usability validation) principles
• Residual use-related risk evaluation
• Preparing and maintaining the Usability Engineering File
• Integration of usability engineering within the Quality Management System
• Common implementation challenges and industry best practices
• Overview of the Usability Engineering Process and required documentation
• Common pitfalls
• Take-home messages, knowledge checks
• Exercise and activities

Candidates working in below domains should attend this training:

• Medical device manufacturers
• Quality Assurance, Regulatory Affairs, Research & Development professionals
• Usability Engineers, User Experience Designers
• Product Management
• Internal and external auditors
• Risk Management Specialists
• Consultants and implementation specialists
• Engineers and Service Providers to the industry

Participants are recommended to have a basic understanding of medical devices, risk management or prior experience in quality management system. Familiarity with regulatory frameworks and quality systems in the medical device industry is beneficial but not mandatory.

• Participants are required to attend and complete the full training to be eligible for the final examination and the certification thereafter.

Medical device manufacturers are expected to demonstrate that their devices can be used safely and effectively by the intended users under the intended conditions of use. Regulatory authorities worldwide increasingly expect manufacturers to incorporate usability engineering into their product development processes and to maintain objective evidence supporting these activities. Whether you are involved in product design, regulatory affairs, quality assurance, risk management or product development, this training provides the practical knowledge needed to support compliant product development while improving user safety and product usability. Participants successfully completing the full training and examination will gain a recognized certification and competency that is valuable for roles in quality assurance, regulatory affairs, research and development of medical devices.

By completing this course, attendees will be able to:

• Understand the purpose, scope and key requirements of IEC 62366-1:2015+A1:2020 and its role in medical device development.
• Understand the usability engineering process and its application.
• Contribute effectively to the implementation and continual improvement of usability engineering activities
  within their organization.

• Learners are eligible to undertake an online examination on completing the full training.
• Classroom exercises will be spread across 2 days of the training.
• Learners are required to successfully complete the final examination to be eligible for the certification. • Examination is conducted online and will consist of scenario-based multiple-choice questions.
• Exam duration: 60 minutes
• Passing criteria: 70%

Learners who pass the final examination are awarded a successful completion certificate by TÜV SÜD South Asia which mentions that the candidate has passed the final examination.

1. When can I get the certificate?

Certification for the Usability Engineering in Medical Devices based on IEC 62366-1:2015+AMD1:2020 Implementation Training will be issued within 14 working days from the date of exam submission.

2. When can I get the training material and invite?

Training materials, invitation and other details are shared after completing the prerequisites.

3. How do I pay the fees for training and examination?
Online mode

4. What are the benefits of the Usability Engineering in Medical Devices based on IEC 62366-1:2015+AMD1:2020 Implementation Training?
The Implementation Training on Usability Engineering in Medical Devices is a two days training which equips professionals with practical skills in implementing key requirements of IEC 62366-1:2015+A1:2020 and its role in medical device development. It will help you lead or support usability engineering of deivces with foundational knowledge and practical insights that support the industry.

5. What if I fail in the final examination?

Participants are permitted to take two attempts to the final examination. The second attempt to the final examination is provided on a chargeable basis. Please write to us via email requesting for a second attempt to the final examination.

6. Is there any refund policy for the paid fees?
Please refer to Cancellation and Refund policy page.